CTRI/2024/03/064154招募中3 期
ATHENA: Effects of ziltivekimab versus placebo on heart failure symptoms and physical functionin patients with heart failure with mildly reduced or preserved ejection fraction and systemicinflammation - NN6018-4914 (ATHENA)
ovo Nordisk A S0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
- •2.Age 18 years or above at the time of signing informed consent.
- •3.Serum hs-CRP greater than equal to 2mg per L at screening visit 1
- •4.NT-proBNP greater than or equal to 225 pg per mL (375 pg per mL for patients with atrial fibrillation or flutter) at screening.
- •5.Diagnosis of heart failure (NYHA Class II-III).
- •6.LVEF greater than 40% documented by echocardiography within 12 months prior to or at screening (visit 1). The LVEF must be documented in medical records and the most recent measurement must be used to determine eligibility with no interim event signalling potential deterioration in ejection fraction (e.g. MI or HF hospitalisation).
- •Structural heart disease and slash or functional heart disease documented by echocardiography within
- •12 months prior to or at screening (visit 1) showing at least one of the following:
- •1.LA volume index greater than 34 mL per m2
- •2.LA diameter greater than or equal to 3.8 cm
- •3.LA length greater than or equal to 5.0 cm
- •4.LA area greater than or equal to 20 cm2
- •5.LA volume greater than or equal to 55 mL
- •6.Intraventricular septal thickness greater than or equal to 1.1 cm
- •7.Posterior wall thickness greater than or equal to 1.1 cm
- •8.LV mass index greater than or equal to 115 g per m2 in men or greater than or equal to 95 g per m2 in women
- •9.E per e (mean septal and lateral) greater than or equal to 10
- •10.e (mean septal and lateral) lesser than 9 cm per s
- •8.No heart failure hospitalisations or urgent heart failure visits between screening and
- •randomisation
- •9.Able to perform the 6MWT at screening with a minimum distance of 100 metres b
- •10.KCCQ clinical summary score lesser than 80 at screening
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •1. Known or suspected hypersensitivity to study intervention or related products.
- •2. Previous randomisation in this study.
- •3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing
- •potential and not using a highly effective contraceptive method, as defined in Appendix 4
- •4. Participation (i.e., signed informed consent) in any other interventional clinical study of an
- •approved or non-approved investigational medicinal product within 30 days prior to screening
- •(visit 1).
- •5. Participation in any clinical study of an approved or non-approved device for the treatment of heart failure within 30 days prior to screening (visit 1).
- •6. Any disorder which in the investigator’s opinion might jeopardise participant’s safety or
- •compliance with the protocol.
- •7. Inadequate standard of care treatment which in the investigator’s opinion makes participation in
- •the study inappropriate.
- •8. Unstable medical therapy for heart failure (including dose of diuretics) within 14 days prior to screening visit (visit 1) (at the discretion of the investigator).
- •Laboratory values
- •9. Absolute neutrophil count lesser than 2x109 per L at screening (visit 1).
- •10. Platelet count lesser than 120×109 per L at screening (visit 1).
- •11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2.5 × upper limit of normal at screening (visit 1).
- •12. Active hepatitis C (positive anti-HCV and detectable HCV RNA) or hepatitis B (positive
- •HBsAg and or positive anti-HBc with detectable HBV DNA) at screening (visit 1). (Note: Participants with positive anti-HBc and undetectable HBV DNA can be enrolled;
- •Medical conditions – cardiovascular
- •13. Myocardial infarction, stroke, unstable angina pectoris, transient ischaemic attack, or heart
- •failure hospitalisation within 30 days prior to screening (visit 1).
- •14. Systolic blood pressure greater than or equal to 180 mmHg at screening (visit 1). If the systolic blood pressure is 160-
- •179 mmHg, the patient should be receiving greater than or equal to 3 antihypertensive drugs. (Note: Potential
- •participants may be retested for this criterion within the visit window and without rescreening,
- •at the discretion of the investigator).
- •15. Heart rate above 110 or below 40 beats per minute as evaluated on the ECG performed at
- •screening (visit 1) (Note: Potential participants may be retested for this criterion within the visit
- •window and without rescreening, at the discretion of the investigator).
- •16. Planned coronary, carotid or peripheral artery revascularisation known during the screening
- •period (visit 1). (Note: planned coronary angiogram is not exclusionary).
- •17. Planned cardiac device or atrial flutter or atrial fibrillation ablation procedure known during the
- •screening period (visit 1).
- •18. Major cardiac surgical, non-cardiac surgical, or major endoscopic procedure (thoracoscopic or
- •laparoscopic) within the past 60 days prior to randomisation (visit 2) or any major surgical
- •procedure planned at the time of randomisation (visit 2).
- •19. Left Ventricular Assist Device (LVAD) implantation or heart transplantation
- •20. Heart failure due to infi
研究者
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